InfertilityNCT02329483
Monitoring the Early Follicular Phase With Androstenedione in Low-dose Step-up Ovulation Induction in High Responders
An observational study of Infertility and Ovarian Hyperstimulation Syndrome, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to predefine the threshold FSH doses during the early follicular phases in low- dose step-up ovulation induction cycles used to treat anticipated high responders by monitoring total testosterone and androstenedione blood levels. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Ovarian Hyperstimulation Syndrome
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Primary/Secondary Infertile patients (couples); ovarian high response to ovulation induction anticipated; with mild male factor or without any male factor. Hysterosalpingography reveals patent uterine tubes and normal uterine cavity.
Who may be able to join
- Primary/Secondary infertile women; aged 20-35 years of age
- High ovarian response to ovulation induction anticipated.(Antral follicle count on the 3rd day of cycle>10)
- Mild male factor or normal sperm parameters
- Normal anatomic findings with the HSG
- Eugonadotropic
- Normal blood prolactin and TSH levels
Who cannot join
- Amenorrheic women
- Women with Diabetes Mellitus
- Body Mass Index: <22 or >30
- Age<20 or >35 years old
- Hormonal abnormalities: regarding prolactin, TSH
- Hypo- or Hypergonadotropic women
Show all 9Show fewer
- Additional medical or surgical disease
- Ovarian cysts
- Previous ovarian surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bagcilar Training and Research Hospital
Istanbul, 34200
Eser S Ozyurek, MD, +905309322345, eozyurek@yahoo.com
Mustafa U Karacaoglu, MD, dr.uner@hotmail.com
About this study
Official title: Early Follicular Phase Androstenedione Monitoring During Low-dose Step-up Induction of Ovulation in High Responders
This study aims to predefine the threshold FSH doses during the early follicular phases in low- dose step-up ovulation induction cycles used to treat anticipated high responders by monitoring total testosterone and androstenedione blood levels. The blood levels of total testosterone and androstenedione levels will be measured in patients at the starting day and at every control day when vaginal sonographic folliculometries and blood estradiol measurements are made. Hence, we are aiming to define an early monitoring parameter by which we will be able to define a follicular response to treatment before estradiol rise or apparently selected follicular growth.
Read the detailed description
50 patients with anticipated high ovarian response, who are being planned to be conventionally treated with low-dose step-up ovulation induction and intrauterine insemination will be analysed in this study. At every control day including the start day, blood samples taken for blood estradiol (and if required progesterone) measurements will be used to measure blood androstenedione and total testosterone levels, as well. Hence, we will have defined an early parameter for defining follicular response in the first 5-7 days of low-dose step-up ovulation induction. Low-dose step-up ovulation induction will be started at 50-75Units/day of rhFSH and the dose will be increased at not earlier than the 7th day at an increment of +37,5Units/day unless a response is observed ( which is at least a 10mm follicle, selected for growth). If more than 3 dominant follicles are selected, the cycle will be cancelled. Otherwise, when at least one follicle >16mm is obtained, a 150Microgram sc. injection will be administered for ovulation trigger and intrauterine insemination made at the 34th-36th hours.
- Conditions
- Infertility, Ovarian Hyperstimulation Syndrome
- Keywords
- Infertility, Ovulation induction, Low-dose step-up protocol, Ovarian high responder, Androgens, Androstenedione, Testosterone, rhFSH
- Medical subject headings
- Infertility, Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High responder infertile patients | Ovarian high responder patients who are being planned for low-dose step-up protocol ovulation induction and intrauterine insemination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood androstenedione and testosterone levels.
Patterns of blood androstenedione and testosterone levels with respect to the regular monitoring parameters and relations to secondary outcomes.
Measured: within 10-20 days
Secondary outcomes (4)
Pregnancy
blood hCG level >10mIU/mlt
Measured: 20-30 days
Cycle cancellation
cancellation of treatment despite 2 rounds of dose step-up
Measured: within 10-20 days
Ovarian hyperstimulation
Enlarged ovaries, abdominal ascites, pleural effusion, hemoconcentration, abdominal swelling
Measured: 10-30 days
Need for dose step-up
if at the 7th day of a dose, no follicle(s)>10mm are observed then the dose is increased
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eser Sefik Ozyurek, Bagcilar Training and Research Hospital
- Investigators
- Eser S Ozyurek, MD, Study director, Bagcilar Training and Research HospitalErdal Kaya, Prof Dr, Study chair, Bagcilar Training and Research HospitalMustafa U Karacaoglu, MD, Study chair, Bagcilar Training and Research HospitalEvrim E Kovalak, MD, Study chair, Bagcilar Training and Research HospitalErdinc Ergul, MD, Study chair, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329483
- Sponsor's protocol ID
- BagcilarTRH
- Status last verified
- Apr 2015
- First submitted
- 29 Dec 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ozyurek ES, Yoldemir T, Artar G. Androstenedione response to recombinant human FSH is the most valid predictor of the number of selected follicles in polycystic ovarian syndrome: (a case-control study). J Ovarian Res. 2017 May 12;10(1):34. doi: 10.1186/s13048-017-0330-7.
PubMed 28494798
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Follicular Phase Androstenedione Monitoring During Low-dose Step-up Induction of Ovulation in High Responders
- ClinicalTrials.gov ID
- NCT02329483
- Acronym / sponsor ID
- BagcilarTRH
- Conditions
- Infertility, Ovarian Hyperstimulation Syndrome
- Keywords
- Infertility, Ovulation induction, Low-dose step-up protocol, Ovarian high responder, Androgens, Androstenedione, Testosterone, rhFSH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Dec 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to predefine the threshold FSH doses during the early follicular phases in low- dose step-up ovulation induction cycles used to treat anticipated high responders by monitoring total testosterone and androstenedione blood levels. The blood levels of total testosterone and androstenedione levels will be measured in patients at the starting day and at every control day when vaginal sonographic folliculometries and blood estradiol measurements are made. Hence, we are aiming to define an early monitoring parameter by which we will be able to define a follicular response to treatment before estradiol rise or apparently selected follicular growth.
Detailed description
50 patients with anticipated high ovarian response, who are being planned to be conventionally treated with low-dose step-up ovulation induction and intrauterine insemination will be analysed in this study. At every control day including the start day, blood samples taken for blood estradiol (and if required progesterone) measurements will be used to measure blood androstenedione and total testosterone levels, as well. Hence, we will have defined an early parameter for defining follicular response in the first 5-7 days of low-dose step-up ovulation induction. Low-dose step-up ovulation induction will be started at 50-75Units/day of rhFSH and the dose will be increased at not earlier than the 7th day at an increment of +37,5Units/day unless a response is observed ( which is at least a 10mm follicle, selected for growth). If more than 3 dominant follicles are selected, the cycle will be cancelled. Otherwise, when at least one follicle >16mm is obtained, a 150Microgram sc. injection will be administered for ovulation trigger and intrauterine insemination made at the 34th-36th hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High responder infertile patients | – | –Ovarian high responder patients who are being planned for low-dose step-up protocol ovulation induction and intrauterine insemination. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Primary/Secondary Infertile patients (couples); ovarian high response to ovulation induction anticipated; with mild male factor or without any male factor. Hysterosalpingography reveals patent uterine tubes and normal uterine cavity.
Key inclusion criteria (6 listed)
- Primary/Secondary infertile women; aged 20-35 years of age
- High ovarian response to ovulation induction anticipated.(Antral follicle count on the 3rd day of cycle>10)
- Mild male factor or normal sperm parameters
- Normal anatomic findings with the HSG
- Eugonadotropic
Key exclusion criteria (9 listed)
- Amenorrheic women
- Women with Diabetes Mellitus
- Body Mass Index: <22 or >30
- Age<20 or >35 years old
- Hormonal abnormalities: regarding prolactin, TSH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood androstenedione and testosterone levels.
Time frame: within 10-20 days
Patterns of blood androstenedione and testosterone levels with respect to the regular monitoring parameters and relations to secondary outcomes.
4 secondary outcomes
Pregnancy
Time frame: 20-30 days
Cycle cancellation
Time frame: within 10-20 days
Ovarian hyperstimulation
Time frame: 10-30 days
Need for dose step-up
Time frame: 7-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Derived from this study: PubMed 28494798Ozyurek ES, Yoldemir T, Artar G. Androstenedione response to recombinant human FSH is the most valid predictor of the number of selected follicles in polycystic ovarian syndrome: (a case-control study). J Ovarian Res. 2017 May 12;10(1):34. doi: 10.1186/s13048-017-0330-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eser S Ozyurek, MD study director
Bagcilar Training and Research Hospital
Erdal Kaya, Prof Dr study chair
Bagcilar Training and Research Hospital
Mustafa U Karacaoglu, MD study chair
Bagcilar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Ovarian Hyperstimulation Syndrome, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eser S Ozyurek, MD (+905309322345, eozyurek@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood androstenedione and testosterone levels. (time frame: within 10-20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.